A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
NCT06533475 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-11-26
Summary
The purpose of the study is to estimate the relative bioavailability of a new minzasolmin tablet formulation versus reference 'granules in capsule' formulation in healthy participants and to evaluate the effect of food with the new tablet formulation on the pharmacokinetics (PK) of minzasolmin.
Conditions
- Healthy Participants
Interventions
- DRUG
-
Minzasolmin tablet formulation under fasting condition
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition
- DRUG
-
Minzasolmin Granules in capsule under fasting condition
Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition
- DRUG
-
Minzasolmin tablet formulation under fed condition
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition
Sponsors & Collaborators
-
UCB Biopharma SRL
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-06
- Primary Completion
- 2024-11-17
- Completion
- 2024-11-17
Countries
- Germany
Study Locations
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